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An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates

NCT06686628 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-04-23

No results posted yet for this study

Summary

This is an open-label, single group, 2-period, Phase 1, single-sequence study. The study duration will be up to 342 days. The treatment period will be up to Week 29, where Week 29 is defined as End of Treatment (last amlitelimab administration at Week 25).

The number of visits will be 23 or 21 visits for participants who decide to continue amlitelimab therapy in the long-term extension study LTS17367 (RIVER-AD) study.

Conditions

  • Dermatitis Atopic

Interventions

DRUG

Amlitelimab

Pharmaceutical form: Injection solution Route of administration: SC injection

DRUG

Midazolam

Pharmaceutical form: Solution Route of administration: Oral

DRUG

Caffeine

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

Metoprolol

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

Omeprazole

Pharmaceutical form: Capsule Route of administration: Oral

DRUG

Warfarin

Pharmaceutical form: Tablet Route of administration: Oral

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2025-11-21
Completion
2026-04-02

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06686628 on ClinicalTrials.gov